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Tuesday, July 26, 2011

Medical Ghostwriting -- How Scary Is It?

"One published survey identified 182 medical education
and communication companies (MECCs) 
operating in the United States in 2001."
(G.A. Golden et al., "Medical Education and Communication Companies: 
An Updated In-depth Profile, 
The Journal of Continuing Education in the Health Professions, Winter 2002). 

Leemon McHenry, reports that organizations of medical writers in the United States and Europe conduct seminars and conferences, and publish their own professional journals. In addition to the preparation of manuscripts, posters and slides, the MECCs are engaged in promotional activities such as the organization of advisory board meetings with academics to prepare the ‘launch’ of a new drug or a new indication for a drug (e.g., adolescent depression, high cholesterol or social anxiety disorder).

MECCs also prepare regulatory submissions, organize continuing medical education (CME) for physicians, dinner meetings, satellite symposia and develop promotional media (CDs, DVDs and websites). Some companies specialize, while others perform multiple functions.

The MECCs or public relations firms charge $18,000 to $40,000 per manuscript. (Leemon McHenry, "Of Sophists and Spin-Doctors: Industry-Sponsored Ghostwriting and the Crisis of Academic Medicine, Mens Sana Monographs, December 22 2009)

What Is "Ghostwriting"?
Medical ghostwriting refers to the practice in which professional writers and other parties are paid — commonly (but by no means always) by pharmaceuticals and medical devices manufacturers — to produce manuscripts for conference presentations, scientific publications, explicitly promotional distributions, patient education materials, continuing professional education activities' contents, and other communications.

Ghostwriting may involve the act of a drug company producing a journal article aimed at either counteracting criticism of a drug or embellishing its benefits. Usually, the drug maker hires a professional writing company to draft the article, and recruits a physician to sign off as the author. Once the article has been published, drug sales reps often present copies of the piece to physicians as evidence that the drug covered in the article is safe and effective. ("Ghostwriting Prevalent In Medical Journals, Study Says,", September 21 2009)

According to Sergio Sismondo, "It has been repeatedly and firmly established that pharmaceutical company funding strongly biases published results in favor of the company's products. Ghost management amplifies that bias, because when one set of commercial interests exerts influence at multiple stages of research, writing, and publication, it will shape the resulting article. In turn, bias affects medical opinion and practice, and ultimately, patients." (S. Sismondo, "Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry? PLoS Med. 4, September 2007).

A Closer Look at Ghostwriting

Just because a manuscript is funded by pharmaceuticals and medical devices manufacturers doesn't make it corrupt or deceptive. One difference between a good manuscript and a misleading one can be noted: If the academic “author” has been marginalized in the process, sought only for the authority of his name and no longer for his knowledge or expertise, it is evident that something is wrong. When operated in this way, medical science is reduced to a form of marketing, which draws its authority from traditional academic science. (Phil Davis, "Ghosts in the Machine -- The Industry of Medical Authorship," The Scholarly Kitchen, November 4 2010)

The Association of American Medical Colleges has defined ghostwriting “as the provision of written material that is officially credited to someone other than the writer(s) of the material. Transparent writing collaboration with attribution between academic and industry investigators, medical writers, and/or technical experts is not ghostwriting. The unacknowledged, undisclosed provision of content should not be permitted under any circumstances." ("SMPP Applauds AAMC Clarification on Ghostwriting Versus Transparent Writing Collaboration in Scientific Publications,", July 7 2008)

AAMC further provides the following recommendation: “Academic medical centers should prohibit physicians, trainees, and students from allowing their professional presentations of any kind, oral or written, to be ghostwritten by any party, industry or otherwise."

Al Weigel, Chairman of ISMPP’s Ethics Committee says, “AAMC’s guidelines provide a clear distinction between medical writing and ghostwriting/ghost authoring that is in line with the International Society for Medical Publication Professionals Code of Ethics, which is intended to promote quality clinical publication practices.”

Ghostwriting And Continued Research

Here are some conclusions based on recent study. (Peter C. Gøtzsche, Jerome P. Kassirer, Karen L. Woolley, Elizabeth Wager, Adam Jacobs, Art Gertel, Cindy Hamilton; "What Should Be Done To Tackle Ghostwriting in the Medical Literature?" PLoS Med 6; February 3 2009)

The authors encourage the mandatory use of a checklist that could help editors detect ghostwriting and help authors avoid ghostwriters. The site:

"This checklist prompts authors to acknowledge professional medical writers and their funding source, to confirm that the authors controlled the main points, outcomes, and data reported in the manuscript, and to verify that medical writers could provide evidence that guidelines on ethical writing practices were followed....

"In conclusion, we believe the debate about ghostwriting needs to shift from whether authors used writers to whether writing assistance was appropriate and adequately disclosed. Professional medical writers are trained to provide appropriate assistance and to insist on disclosure. Since professional medical writers work with experienced and inexperienced authors from around the world on a daily basis, they could be valuable allies in the efforts to tackle ghostwriting."

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